M. Pharm: Research Methodology and biostatics

Lecture Delivered By..
Prof. Sonali R. Pawar
UNIT III
Research
Methodology
& Biostatistics

Syllabus Contents:
a) Medical Research: History
b) Values in medical ethics
c) Autonomy, beneficence, non– maleficence,
d) Double effect, conflicts between autonomy and
beneficence/non– maleficence, euthanasia.
e) Informed consent, Confidentiality
f) Criticisms of orthodox medical ethics
g) Importance of communication
h) Control resolution
i) Guidelines, ethics committees
j) Cultural concerns, truth telling
k) Online business practices
l) Conflicts of interest, referral
m) Vendor relationships
n) Treatment of family members
o) Sexual relationships, fatality.

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02
Medical History:
Historically, Western medical ethics may be
traced to guidelines on the duty of
physicians in antiquity, such as the
Hippocratic Oath, and early rabbinic and
Christian teachings.
In the medieval and early modern period,
the field is indebted to Muslim physicians
such as; 0
1) Ishaq bin Ali Rahawi (who wrote the
Conduct of a Physician, the first book
dedicated to medical ethics) and
2) Muhammad ibn Zakariya ar-Razi (known
as Rhazes in the West), Jewish thinkers
such as Maimonides,
3) Roman Catholic scholastic thinkers such
as Thomas Aquinas, and the case-oriented
analysis (casuistry) of Catholic moral
theology.
By the 18th and 19th centuries, medical
ethics emerged as a more self-conscious
discourse.
For instance, authors such as Thomas Percival
wrote about “medical jurisprudence” and
reportedly coined the phrase “medical
ethics.”
Percival’s guidelines related to physician
consultations have been criticized as
being excessively protective of the home
physicians reputation.
These intellectual traditions continue in:
1) Catholic,
2) Islamic and
3) Jewish medical ethics.

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04
In 1847, the American Medical
Association adopted its first code of
ethics, with this being based in large part
upon Percival’s work(Roman:legendary
king).
While the secularized (separate from
religion) field borrowed largely from
Catholic medical ethics, in the 20th
century a distinctly liberal Protestant
approach was articulated by thinkers
such as JosephFletcher.
In the 1960s and 1970s, building upon
liberal theory and procedural justice,
much of the discourse of medical
ethics went through a dramatic shift
and largely reconfigured itself into
bioethics.
Since the 1970s, the growing influence of
ethics in contemporary medicine can
be seen in the increasing use of
Institutional Review Boards to
evaluate experiments on human
subjects, the establishment of
hospital ethics committees, the
expansion of the role of clinician
ethicists, and the integration of
ethics into many medical school
curricula.

PAGE
06 b) Values in medical ethics:
Medical History:
Medical history of a patient to review his/her
health history.
It’s a very important part of their workflow to
ensure they’re providing the best care and
treatment.
A patient’s medical history may include details
about past diseases, illnesses running in the
family, previous diagnoses, medical abstract,
therapies, allergies, and medication.
Presenting complaint:
▪ History of presenting complaint ▪
Past medical history
▪ Past surgical history
▪ Drug history and allergies
▪ Family history
▪ Social history
The study of moral values and judgments
as they apply to medicine.
As a scholarly discipline, medical ethics
encompasses its practical application in
clinical settings as well as work on its
history, philosophy, theology, and
sociology.
Medical ethics tends to be understood
narrowly as an applied professional ethics,
whereas bioethics appears to have worked
more expansive concerns, touching upon
the philosophy of science and issues of
biotechnology.
Still, the two fields often
overlap and the distinction is
more a matter of style than
professional consensus.
Medical ethics shares many principles with
other branches of healthcare-ethics, such
as nursing ethics.

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08
c) Autonomy:
1. Autonomy (Voluntas aegroti suprema
lex.) – The patient has the right to
refuse or choose their treatment.
2. Beneficence (Salus aegroti suprema
lex.) – A practitioner should act in the
best interest of the patient.
3. Non-maleficence (Primum non nocere)
–“First, do noharm”
4. Justice (Fairness and equality) –
Concerns the distribution of scarce
health resources, and the decision
of who gets what treatment.
5. Dignity – The patient (and the person
treating the patient) have the right
to dignity.
6. Truthfulness and honesty – The
concept of informed consent has
increased in importance
since the historical events of the
Doctors’ Trial of the Nuremburg
trials and Tuskegee Syphilis Study
The principle of autonomy recognizes the
rights of individuals to selfdetermination.
Autonomy has become more important
as social values to define medical
quality in terms of outcomes
Autonomy is a general indicator of
health.
Many diseases are
characterized by loss of
autonomy, in variousmatters.
This makes autonomy an indicator for
both personal well-being, and for the
well-being of the profession.
Sixvalues applyto medicalethics:

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10Beneficence: Non– maleficence:
The term beneficence refers to
actions that promote the
wellbeing of others.
In the medical context, this means taking
actions that serve the best interests of
patients.
However, uncertainty surrounds
the precise definition of which
practices do in fact help
patients.
James Childress and Tom Beauchamp in
Principle of Biomedical Ethics (1978)
identify beneficenceas one of the core
values of health care ethics.
Some scholars, such as Edmund
Pellegrino, argue that beneficence is the
only fundamental principle of medical
ethics.
The concept of non-maleficence is
embodies by the phrase, “first, do no
harm,” or the Latin, primum non
nocere.
Many consider that should be the
main or primary consideration
(hence primum): that it is more
important not to harm your patient,
than to do them good.
This is partly because enthusiastic
practitioners are prone to using
treatments that they believe will do
good, without first having evaluate them
adequately to ensure they do no (or
only acceptable levelsof) harm.

PAGE
12 Much harm has been done to patients as
a result. It is not only more important to
do no harm than to do good; it is also
important to know how likely it is that
your treatment will harm a patient.
So a physician should go further than
not prescribing medications they
know to be harmful – he or she should
not prescribe medications (or
otherwise treat the patient) unless
s/he knows that the treatment is
unlikely to be harmful; or at the very
least, that patient understands the
risks and benefits, and that the likely
benefits outweigh the likely risks.
In practice, however, many treatments
carry some risk of harm.
In some circumstances, e.g. in desperate
situations where the outcome without
treatment will be grave, risky treatments
that stand a high chance of harming the
patient will be justified, as the risk of not
treating is also very likely to do harm.
So the principle of non-maleficence is not
absolute, and must be balanced against
the principle of beneficence (doing good).
Non– maleficence

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14
d) Double effect:
Some interventions undertaken by
physicians can create a positive outcome
while unintentionally doing foreseeable
harm. The
combination of these two circumstances is
known as the “double effect”.
A commonly cited example of this
phenomenon is the use of morphine in the
dying patient.
Such use of morphine can ease the
pain and suffering of the patient,
while simultaneously hastening the
demise of the patient through
suppression of therespiratory system.
Some American physicians interpret the
non- maleficence principle to exclude
the practice of euthanasia, though not
all concur.
Probably the most extreme example in
recent history of the violation of the non-
maleficence dictum was Dr. Jack Kevorkian,
who was convicted of second-degree
homicide in Michigan in 1998 after
demonstrating active euthanasia on the TV
news show, 60 Minutes.
d)Euthanasia
Conflict between autonomy and
beneficence/non– maleficence,
euthanasia

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16
e) Informed Consent:
Informed consent in ethics usually
refers to the idea that a person must
be fully-informed about and
understand the potential benefits and
risks of their choiceof treatment.
An uninformed person is at risk of
mistakenly making a choice not
reflective of his or her values or wishes.
It does not specifically mean the
process of obtaining consent, nor the
specific legal requirements, which
vary from place to place, for capacity
toconsent.
Patients can elect to make their own
medical decisions, or can delegate
decision-making authority to
another party.
If the patient is incapacitated, laws around
the world designate different processes for
obtaining informed consent, typically by
having a person appointed by the patient
or their next of kin make decisions for
them.
The value of informed consent is closely
related to the values of autonomy and truth
telling.

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18
e) Confidentiality:
Confidentiality is commonly
applied to conversations between
doctors and patients.
This concept is commonly known
as patient- physician privilege.
Legal protections prevent physicians
from revealing their discussions
with patients, even under oath in
court.
Confidentiality is mandated in America by
HIPAA laws, specifically the Privacy Rule,
and various state laws, some more
rigorous than HIPAA.
However, numerous exceptions to the
rules have been carved out over the years.
For example, many states require physicians
to report gunshot wounds to the police and
impaired drivers to the Department of
Motor Vehicles.
Confidentiality is also challenged in
cases involving diagnosis of a sexually
transmitted disease in a patient who
refuses to reveal the diagnosis to a
spouse, and in termination of a
pregnancy in an underage patient,
without the knowledge of the patient’s
parents.
Traditionally, medical ethics has viewed
the duty of confidentiality as a
relatively non-negotiable tenet of
medicalpractice.
More recently, critics like Jacob Appel have
argued for a more nuanced approach to
the duty that acknowledges the need
for flexibility in many cases.

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20
f) Criticisms of orthodox medical
ethics
It has been argued that mainstream medical
ethics is biased by the assumption of a
framework in which individuals are not simply
free to contract with one another to provide
whatever medical treatment is demanded,
subject to the ability to pay.
Because a high proportion of medical care is
typically provided via the welfare state (ie.
Medicare), and because there are legal
restrictions on what treatment may be
provided and by whom, an automatic
divergence may exist between the wishes of
patients and the preferences of medical
practitioners and other parties.

PAGE
22
g) Importance ofCommunication
Many so-called “ethical conflicts” in
medical ethics are traceable back to a lack
of communication.
Communication breakdowns
between patients and their
healthcare team, between family
members, or between members of
the medical community, can all
lead to disagreements and strong
feelings.
These breakdowns should be remedied,
and many apparently insurmountable
“ethics” problems can be solved with
open lines of communication.
To ensure that appropriate ethical values
are being applied within hospitals,
effective hospital accreditation
requires that ethical considerations
are taken into account, for example with
respect to physician integrity, conflicts
of interest, research ethics and organ
transplantation ethics.
h) Control andResolution

PAGE
24 There are various ethical guidelines.
For example, the Declaration of
Helsinki is regarded as authoritative
in human research ethics.
In the United Kingdom, General
Medical Council provides clear
overall modern guidance in the
form of its ‘Good Medical Practice’
statement.
Other organizations, such as the
Medical Protection Society and a
number of university
departments, are often
consulted by British doctors
regarding issues relating to
ethics.
i) Guidelines
Often, simple communication is not
enough to resolve a conflict, and a hospital
ethics committee must convene to decide a
complex matter.
These bodies are composed primarily of
health care professionals, but may also
include philosophers, lay people, and clergy
– indeed, in many parts of the world their
presence is considered mandatory in order
to provide balance.
i) EthicsCommittees
U.S. recommendations suggest that
Research and Ethical Boards (REBs) should
have five or more members, including at
least one scientist, one non- scientist, and
one person not affiliated with the
institution.
The REB should include people
knowledgeable in the law and standards
of practice and professional conduct.
Special memberships are advocated for
handicapped or disabled concerns, if
requiredby the protocol under review.

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26
j) CulturalConcerns
Culture differences can create difficult
medical ethics problems.
Some cultures have spirited or magical
theories about the origins of disease, for
example, and reconciling these beliefs
with the tenets of Western medicine can
be difficult.
Some cultures do not place a great
emphasis on informing the patient of
the diagnosis, especially when cancer is
the diagnosis.
Even American culture did not emphasize
truth- telling in a cancer case, up until
the 1970s.
In American medicine, the principle of
informed consent takes precedence over
ethical values, and patients are usually at
least asked whether they want to know
the diagnosis.
j) Truth-Telling
Physicians should not allow a conflict of
interest to influence medical judgment.
In some cases, conflicts are hard to
avoid, and doctors have a
responsibility to avoid entering
such situations.
Unfortunately, research has shown that
conflicts ofinterests are very common
among both academic physicians and
physicians in practice.
l)Conflicts ofInterest
k) Online Business Practices
The resources available online are far more
extensive than the personal libraries or
hospital libraries that physicians used in a
print world. • Recently publishers are
experimenting with hybrid journals that offer
their most important content online, while still
publishing print issues. • Today medical library
collections are a mosaic of print and online
content

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28
Forexample, doctors who receive
income from referring patients
for medical tests have been
shown to refer more patients for
medical tests.
This practice is proscribed by
the American College of
Physicians EthicsManual.
Fee splitting and the payments of
commissions to attract referrals of
patients is considered unethical and
unacceptable in most parts of the
world.
l)Referral m) VendorRelationships
Studies show that doctors can be
influenced by drug company
inducements, including gifts and food.
Industry-sponsored Continuing Medical
Education (CME) programs influence
prescribing patterns.
Many patients surveyed in one study
agreed that physician gifts from drug
companies influence prescribing
practices.

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30
Sexual relationships between doctors
and patients can create ethical
conflicts, since sexual consent may
conflict with the fiduciary
responsibility of the physician.
Doctors who enter into sexual
relationships with patients face the
threats of deregistration and
prosecution.
In the early 1990s it was estimated
that 2 ~ 9 % of doctors had violated
this rule.
o) FUTILITY
The concept of medical futility has
been an important topic in
discussions of medical ethics.
What should be done if there is no
chance that a patient will survive
but the family members insist on
advancedcare?
Previously, some articles defined
futility as the patient having
less that a one percent chance of
surviving.
Some of these cases wind up in the
courts.
n) Treatment of Family Members
o) SexualRelationships

PAGE
10
PAGE
32 Advanced directives include living
wills and durable powers of attorney
for health care.
(See also Do NotResuscitate and
cardiopulmonary resuscitation)
In many cases, the “expressed wishes” of
the patient are documented in these
directives, and this provides a framework
to guide family members and health care
professionals in the decision making
process when the patient is
incapacitated.
“Substituted judgment is the concept that
a family member can give consent for
treatment if the patient is unable (or
unwilling) to give consent himself.
The key question for the decision making
surrogate is not, “What would you like to
do?”, but instead, “What do you think
the patient would
want in thissituation?”.
Courts have supported family’s arbitrary
definitions of futility to include simple
biological survival, as in the baby Kcase.
(in which the courts ordered a child born with
only a brain stem instead of a complete brain
to be kept on a ventilator based on the
religious belief that all life must be
preserved)
In some hospitals, medical futility is referred
to as “non-beneficial care.”
Baby Doe Laws establish state protection
for a disabled child’s right to life,
ensuring that this right is protected
even over the wishes of parents or
guardians in cases where they want to
withhold treatment.
Critics claim that this is how the State,
and perhaps the Church, through its
adherents in the executive and the
judiciary, interferes in order to further
its own agenda at the expense of the
patients.

M. Pharm: Research Methodology and biostatics

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